Utilizing Autologous Multipotent Mesenchymal Stromal Cells and β-Tricalcium Phosphate Scaffold in Human Bone Defects: A Prospective, Controlled Feasibility Trial

Biomed Res Int. 2016;2016:2076061. doi: 10.1155/2016/2076061. Epub 2016 Apr 7.

Abstract

The purpose of this prospective controlled study was to compare healing quality following the implantation of ultraporous β-tricalcium phosphate, containing either expanded autologous mesenchymal stromal cells (trial group, 9 patients) or β-tricalcium phosphate alone (control group, 9 patients), into femoral defects during revision total hip arthroplasty. Both groups were assessed using the Harris Hip Score, radiography, and DEXA scanning at 6 weeks and 3, 6, and 12 months postoperatively. A significant difference in the bone defect healing was observed between both groups of patients (P < 0.05). In the trial group, trabecular remodeling was found in all nine patients and in the control group, in 1 patient only. Whereas, over the 12-month follow-up period, no significant difference was observed between both groups of patients in terms of the resorption of β-tricalcium phosphate, the significant differences were documented in the presence of radiolucency and bone trabeculation through the defect (P < 0.05). Using autologous mesenchymal stromal cells combined with a β-tricalcium phosphate scaffold is a feasible, safe, and effective approach for management of bone defects with compromised microenvironment. The clinical trial was registered at the EU Clinical Trials Register before patient recruitment has begun (EudraCT number 2012-005599-33).

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Arthroplasty, Replacement, Hip*
  • Bone Regeneration / physiology
  • Bone Remodeling / drug effects
  • Bone Remodeling / physiology
  • Calcium Phosphates / therapeutic use*
  • Cancellous Bone / drug effects
  • Cancellous Bone / physiopathology
  • Cancellous Bone / surgery
  • Female
  • Femur / physiopathology
  • Femur / surgery
  • Humans
  • Male
  • Mesenchymal Stem Cell Transplantation / methods*
  • Mesenchymal Stem Cells
  • Middle Aged
  • Tissue Scaffolds / chemistry
  • Transplantation, Autologous*
  • Treatment Outcome

Substances

  • Calcium Phosphates
  • beta-tricalcium phosphate